Development and Validation of a RP-HPLC Method for the Determination of Acyclovir in Transdermal Patches

A B S T R A C T The present report describes a rapid and sensitive High Pressure Liquid Chromatography (HPLC) method with UV detection to quantify acyclovir in transdermal patches. After sample preparation with diluent separation of acyclovir was achieved on a Kromasil C18 column (250mm×4.6mm, 5μm particle size) column at 30˚C. The mobile phase consisted of Buffer: Acetonitrile taken in the ratio 60:40 v/v, at a flow rate of 1.0 ml/min, with total run time of 8 min. Detection of acyclovir was done at 253 nm. Method was found to be selective, linear (r2 = 0.999), accurate (recovery, 100.22–100.31%) and precise (RSD, ≤0.52%) in the selected concentration range of 12.5-87.5ppm. Detection and quantitation limit of acyclovir in patch were 0.29 and 1.39ppm, respectively. Transdermal drug delivery systems are becoming more popular in the field of modern pharmaceutics. Different matrix-type transdermal films containing acyclovir was formulated with an objective to study the effect of polymers on the release characters. All the prepared formulations showed good physical stability. The in-vitro permeation studies were performed using Franz diffusion cell. Two in house formulations were selected as best formulations and further assayed by RP-HPLC method.Keywords: Acyclovir, Transdermal patches, RP-HPLC, Method development, Method validation.